Comparison of the Multi-Test II and Skintestor Omni allergy skin test devices.
ABSTRACT Different devices for percutaneous allergy skin testing have demonstrated statistically and clinically significant differences in performance characteristics.
To compare 2 Food and Drug Administration-approved multihead allergy skin testing devices: Multi-Test II (Lincoln Diagnostics) and Skintestor Omni (Greer Laboratories).
Skin tests with glycerinated histamine (6-mg/mL base) and glycerinated saline were applied to 31 adults using Multi-Test II on the volar surface of one forearm and Skintestor Omni on the opposite forearm.
Data were accumulated from 155 histamine sites and 93 negative control sites for each device. Using cutoff wheal sizes of 5 vs 3 mm inclusive to define a positive result, Multi-Test II sensitivity remained at 100%, but specificity increased from 74% to 97%, whereas Skintestor Omni sensitivity decreased from 94% to 87%, and specificity increased from 58% to 88%. For Multi-Test II vs Skintestor Omni, histamine mean (SD) wheal sizes were 9.23 (1.37) vs 7.74 (2.83) mm (P < .001), mean coefficients of variance were 14.8% vs 36.6%, and pooled estimates of variance were 0.642 vs 6.974. Multi-Test II produced similar histamine wheal sizes regardless of test head position used, whereas Skintestor Omni produced statistically significantly smaller wheals at certain test head positions.
Multi-Test II had higher sensitivity and specificity than Skintestor Omni and produced reproducible wheal sizes from all test head positions. Because some Skintestor Omni test head positions produced significantly smaller histamine wheal sizes, skin testing using this device might result in underdiagnosis of allergy.
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ABSTRACT: Allergy skin testing guides developing avoidance plans and writing an immunotherapy prescription. The goal for the allergist is to apply allergen skin testing to the appropriate patient population by using a device that minimizes both false-negative and false-positive findings while minimizing patient discomfort. New skin testing devices continue to be developed with a trend toward production of multiheaded devices. Data on the performance of these devices in a head-to-head prospective fashion are limited. Our goal was to study 8 commonly used devices to compare their performance in a head-to-head fashion. In a prospective, double-blind fashion, the performance of 8 skin test devices was evaluated. Devices were tested with histamine and saline on both the arms and back of each subject. Devices were rotated over 4 testing sessions, at least a week apart, so each device was tested in each anatomic testing location. Performance elements examined included wheal, flare, pain, sensitivity, specificity, and intradevice variability. We found significant differences in all areas of device performance among all devices examined. Multiheaded devices also demonstrated significant intradevice variability and were more painful than single devices. Furthermore, multiheaded devices had larger reactions on the back, whereas single devices had larger reactions on the arms. Statistically significant differences exist among all devices tested. Providers should consider this data when choosing a device that suits their practice setting and ensure that technicians are sufficiently trained on the correct use of that device.Journal of Allergy and Clinical Immunology 09/2005; 116(2):341-6. DOI:10.1016/j.jaci.2005.03.035 · 11.25 Impact Factor
- Clinical allergy 07/1973; 3(2):103-8. DOI:10.1111/j.1365-2222.1973.tb01314.x
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ABSTRACT: Six devices commonly used for immediate hypersensitivity epicutaneous skin testing were compared with regard to precision and diagnostic accuracy. Fifteen subjects were tested on the back to 10 mg/ml of histamine phosphate and 50% glycerosaline by prick technique with a smallpox needle (SN), bifurcated needle (BN), Greer "pen" (GP), and blood lancet, and by puncture with the Morrow-Brown needle (MB) and Multi-Test (MT). Five devices were tested in quintuplicate to histamine and once to glycerosaline in each subject; with MT, five histamine and three glycerosaline sites were used. Analysis of the wheal areas obtained with SN, BN, GP, and MB demonstrated comparable degrees of precision (coefficient of variation). The precision of MT was less than the other devices (p less than 0.05). The blood lancet demonstrated intermediate precision. Twenty-two of 45 (49%) of the glycerosaline skin tests performed with MT were falsely positive, significantly more than the other devices (p = 0.0001). We conclude that MB, BN, GP, and SP are comparable devices for use in immediate hypersensitivity skin testing. The low precision and reliability of MT used for testing on the back would appear to make this device less than adequate for diagnostic or research studies. Its high rate of false positive reactions requires caution in interpretation of results when it is used in the clinical diagnosis of allergy.Journal of Allergy and Clinical Immunology 09/1989; 84(2):168-74. DOI:10.1016/0091-6749(89)90321-7 · 11.25 Impact Factor